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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01004224




Registration number
NCT01004224
Ethics application status
Date submitted
27/10/2009
Date registered
29/10/2009

Titles & IDs
Public title
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
Scientific title
A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies
Secondary ID [1] 0 0
2009-010876-73
Secondary ID [2] 0 0
CBGJ398X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3 0 0
Squamous Lung Cancer With FGFR1 Amplification 0 0
Bladder Cancer With FGFR3 Mutation or Fusion 0 0
Advanced Solid Tumors With FGFR1 Amplication 0 0
Advanced Solid Tumors With FGFR2 Amplication 0 0
Advanced Solid Tumors With FGFR3 Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: BGJ398 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
Timepoint [1] 0 0
23 months
Secondary outcome [1] 0 0
To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations)
Timepoint [1] 0 0
23 months
Secondary outcome [2] 0 0
To determine the pharmacokinetic (PK) profiles of oral BGJ398
Timepoint [2] 0 0
23 months
Secondary outcome [3] 0 0
To evaluate the pharmacodynamic effect of the drug.
Timepoint [3] 0 0
23 months
Secondary outcome [4] 0 0
Assess preliminary anti-tumor activity for patients not in Arm 4.
Timepoint [4] 0 0
23 months

Eligibility
Key inclusion criteria
* Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
* Adequate bone marrow function
* Adequate hepatic and renal function
* Adequate cardiovascular function
* Contraception.

* For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
* For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with primary CNS tumor or CNS tumor involvement
* Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
* History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
* Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
* History or current evidence of cardiac arrhythmia and/or conduction abnormality
* Women who are pregnant or nursing.

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/10/2018
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Austria
State/province [11] 0 0
Vienna
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux Cedex
Country [13] 0 0
France
State/province [13] 0 0
Lyon Cedex
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Montpellier Cedex 5
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Saint-Herblain Cédex
Country [18] 0 0
France
State/province [18] 0 0
Suresnes
Country [19] 0 0
France
State/province [19] 0 0
Toulouse Cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Villejuif Cedex
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Germany
State/province [23] 0 0
Hannover
Country [24] 0 0
Germany
State/province [24] 0 0
Marburg
Country [25] 0 0
Israel
State/province [25] 0 0
Ramat Gan
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Italy
State/province [27] 0 0
FC
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Korea
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
Singapore
State/province [31] 0 0
Singapore
Country [32] 0 0
Spain
State/province [32] 0 0
Andalucia
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Comunidad Valenciana
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
Thailand
State/province [38] 0 0
Bangkok
Country [39] 0 0
Thailand
State/province [39] 0 0
Chiang Mai
Country [40] 0 0
Turkey
State/province [40] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01004224